Pure Red-cell AplasiaNCT00211068
A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa
An observational study of Pure Red-cell Aplasia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 22 sites in 7 countries.
Trial summary
The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pure Red-cell Aplasia
- How many people
- 124 participants
- Where
- 22 sitesin 7 countries
- Study dates
- Mar 2004to Mar 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants having chronic kidney disease and an immune-mediated cause of pure red cell aplasia indicated by the presence of anti-erythropoietin antibodies in their serum at the time of loss of efficacy
Who may be able to join
- History of anemia due to chronic kidney disease
- Pure red cell aplasia (PRCA) associated with erythropoietin-alpha (EPO) treatment
- Treatment with EPO for a minimum of 2 months occurring within more or less 3 months of the reference date (date of loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first observed)
Who cannot join
- History of and information related to past exposure to EPO not available
- History of PRCA or anti-EPO antibody positive status before or after the reference date
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United Kingdom9 sites
Study site
Birmingham
Study site
Brighton
Study site
Bristol
Study site
Chelmsford
Study site
Edinburgh
Study site
London
Study site
Manchester
Study site
Omagh
Study site
Westcliff-on-Sea
France5 sites
Study site
Bois-Guillaume
Study site
Grenoble
Study site
Nantes
Study site
Orléans
Study site
Paris
About this study
Official title: Retrospective Case-control Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa
The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX).
Read the detailed description
This is a multicenter (study conducted at multiple sites), case-control (study that compare individuals with a disease or condition [cases] to a group of individuals without the disease or condition [controls] to determine the possible factor which increased disease incidence), retrospective (a study in which the participants are identified and then followed backward, as time passes) study. Retrospective risk factor data will be collected for control participants matched to the subset of participants in Protocol EPO-IMU-301 identified as having chronic kidney disease and anti-EPO antibody positive PRCA that began while the participant was receiving treatment with EPREX (index participants). For each index participant, up to 4 matched non-PRCA control participants with chronic kidney disease will be enrolled in this study. Approximately 600 control participants will be enrolled in this study. Control participants will be selected from the same site as the index participant and the data will be collected from the date closest to the reference date (loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first seen) that the control participant satisfies all study inclusion and exclusion criteria. The optional pharmacogenomic part (testing for polymorphisms and haploid types of the erythropoietin gene) will be recorded for the control participants who will sign the pharmacogenomics part of the study. No drug administration or treatment will be mandated by this study. Safety evaluation will include assessment of adverse events.
- Conditions
- Pure Red-cell Aplasia
- Being tested
- No intervention
- Keywords
- Pure red-cell aplasia, Chronic kidney failure, Epoetin alfa (Eprex), Erythropoietin, Kidney disease, Anemia
- Medical subject headings
- Red-Cell Aplasia, Pure, Kidney Failure, Chronic, Kidney Diseases, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
Also called EPREX
This study is an observational study. No medication will be provided or administered to the participants. Participants will receive standard-of-care treatment from their individual physicians.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin alfa | Four control patients will be matched to each index patients enrolled in protocol EPO-IMU-301 identified as having chronic kidney disease and an immune-mediated cause of pure red cell aplasia (PRCA) indicated by the presence of anti-erythropoietin (EPO) antibodies in their serum at the time of loss of efficacy. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug
The reference date is the day on which Loss of Efficacy (LOE) was first suspected, where LOE is the date that a drop in hemoglobin of greater than 2 g/dL/month was first seen.
Measured: 1 year prior to the reference date
Study medication-related risk factors: Number of participants who received HSA-free drug
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who administered epoetin alfa in hospital or in clinic
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with the duration of other recombinant human erythropoietins (r-HuEPOs) treatment
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs
Measured: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing
Measured: 6 months prior to the reference date
Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing
Measured: 6 months prior to the reference date
Participant-related risk factors: Number of participants according to age
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to sex
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to race
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to type of renal replacement therapy (if any at the time of the reference date)
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of malnutrition
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of autoimmune disease or positive results of autoimmune testing
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of immune dysregulation
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with uncontrolled hypothyroidism
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of malignancy
Measured: 5 years prior to the reference date
Participant-related risk factors: Number of participants with history of viral infection
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of vaccination
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of frequent transfusions
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with treatment with other subcutaneous medications
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants with treatment with other recombinant human proteins
Measured: 1 year prior to the reference date
Participant-related risk factors: Number of participants who received other concomitant therapy
Measured: 1 year prior to the reference date
Secondary outcomes (1)
Human leukocyte antigen (HLA) typing
The optional pharmacogenomic (use of genetic information to predict whether the study medication will help make a patient well or ill) part of the study will test for polymorphisms and haploid types of the erythropoietin gene. HLA typing will be recorded for the control participants who will sign the pharmacogenomics part of the study.
Measured: 1 year prior to the reference date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pure Red-cell AplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211068
- Sponsor's protocol ID
- CR004408
- Other IDs
- EPO-IMU-403
- Status last verified
- Apr 2013
- First submitted
- 13 Sep 2005
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Case-control Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa
- ClinicalTrials.gov ID
- NCT00211068
- Acronym / sponsor ID
- CR004408
- Conditions
- Pure Red-cell Aplasia
- Keywords
- Pure red-cell aplasia, Chronic kidney failure, Epoetin alfa (Eprex), Erythropoietin, Kidney disease, Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX).
Detailed description
This is a multicenter (study conducted at multiple sites), case-control (study that compare individuals with a disease or condition [cases] to a group of individuals without the disease or condition [controls] to determine the possible factor which increased disease incidence), retrospective (a study in which the participants are identified and then followed backward, as time passes) study. Retrospective risk factor data will be collected for control participants matched to the subset of participants in Protocol EPO-IMU-301 identified as having chronic kidney disease and anti-EPO antibody positive PRCA that began while the participant was receiving treatment with EPREX (index participants). For each index participant, up to 4 matched non-PRCA control participants with chronic kidney disease will be enrolled in this study. Approximately 600 control participants will be enrolled in this study. Control participants will be selected from the same site as the index participant and the data will be collected from the date closest to the reference date (loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first seen) that the control participant satisfies all study inclusion and exclusion criteria. The optional pharmacogenomic part (testing for polymorphisms and haploid types of the erythropoietin gene) will be recorded for the control participants who will sign the pharmacogenomics part of the study. No drug administration or treatment will be mandated by this study. Safety evaluation will include assessment of adverse events.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin alfa | – | Drug: No interventionFour control patients will be matched to each index patients enrolled in protocol EPO-IMU-301 identified as having chronic kidney disease and an immune-mediated cause of pure red cell aplasia (PRCA) indicated by the presence of anti-erythropoietin (EPO) antibodies in their serum at the time of loss of efficacy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants having chronic kidney disease and an immune-mediated cause of pure red cell aplasia indicated by the presence of anti-erythropoietin antibodies in their serum at the time of loss of efficacy
Key inclusion criteria (3 listed)
- History of anemia due to chronic kidney disease
- Pure red cell aplasia (PRCA) associated with erythropoietin-alpha (EPO) treatment
- Treatment with EPO for a minimum of 2 months occurring within more or less 3 months of the reference date (date of loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first observed)
Key exclusion criteria (2 listed)
- History of and information related to past exposure to EPO not available
- History of PRCA or anti-EPO antibody positive status before or after the reference date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAlso: EPREXThis study is an observational study. No medication will be provided or administered to the participants. Participants will receive standard-of-care treatment from their individual physicians. | Drug | Epoetin alfa |
Primary outcome
Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug
Time frame: 1 year prior to the reference date
The reference date is the day on which Loss of Efficacy (LOE) was first suspected, where LOE is the date that a drop in hemoglobin of greater than 2 g/dL/month was first seen.
Study medication-related risk factors: Number of participants who received HSA-free drug
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who administered epoetin alfa in hospital or in clinic
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with the duration of other recombinant human erythropoietins (r-HuEPOs) treatment
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing
Time frame: 6 months prior to the reference date
Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing
Time frame: 6 months prior to the reference date
Participant-related risk factors: Number of participants according to age
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to sex
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to race
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to type of renal replacement therapy (if any at the time of the reference date)
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of malnutrition
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of autoimmune disease or positive results of autoimmune testing
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of immune dysregulation
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with uncontrolled hypothyroidism
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of malignancy
Time frame: 5 years prior to the reference date
Participant-related risk factors: Number of participants with history of viral infection
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of vaccination
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of frequent transfusions
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with treatment with other subcutaneous medications
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with treatment with other recombinant human proteins
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants who received other concomitant therapy
Time frame: 1 year prior to the reference date
1 secondary outcome
Human leukocyte antigen (HLA) typing
Time frame: 1 year prior to the reference date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pure Red-cell Aplasia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, France, Sweden, Brazil, Norway and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug (time frame: 1 year prior to the reference date). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.